ISO 11137 : 1995

1 Scope
2 Normative references
3 Definitions
4 Documentation
5 Personnel
6 Sterilization process validation
6.1 General
6.2 Product qualification
6.2.1 Product and packaging materials evaluation
6.2.2 Sterilization dose selection
6.2.3 Transfer of sterilization dose
6.3 Installation qualification
6.3.1 Equipment documentation
6.3.2 Equipment testing
6.3.3 Equipment calibration
6.3.4 Irradiator dose mapping
6.4 Process qualification
6.4.1 Determination of product loading pattern
6.4.2 Product dose mapping
6.5 Certification
6.6 Maintenance of validation
6.6.1 Calibration programme
6.6.2 Irradiator requalification
6.6.3 Sterilization dose auditing
7 Routine process control
7.1 Process specification
7.2 Product handling
7.2.1 Product shipment and receipt
7.2.2 Pre- and post-irradiation product storage
7.3 Routine and preventive maintenance
7.4 Product irradiation
7.4.1 Process control
7.4.2 Process interruption
7.4.3 Dose monitoring
7.5 Process documentation
7.6 Sterilization acceptance
8 Management and control
Annexes
A Device and packaging materials qualification
B Dose setting methods for radiation sterilization
C Dosimeters, dosimetry and associated equipment
D Bibliography

Specifies requirements for validation, process control and routine monitoring in the radiation sterilization of health care products, and applies to continuous and batch type gamma irradiators using the radionuclides 60 Co and 137 Cs, and to irradiators using a beam from an electron or x-ray generator.